LaJolla to study Riquent as treatment for lupus patients

By E. Janene Geiss

Philadelphia, Jan. 11 - La Jolla Pharmaceutical Co. said Wednesday that it will begin a multi-dose clinical study in lupus patients of its drug candidate Riquent, which will evaluate on an ongoing basis the ability of higher doses of Riquent to further reduce antibodies to double-stranded DNA over the next year.

Antibodies to double-stranded DNA are associated with the deadly progression of kidney disease in lupus that often results in treatment with drugs that have life-threatening side effects and result in increased hospitalization, according to a company news release.

This study is part of the company's overall clinical program that includes an ongoing phase 3 clinical trial to evaluate the use of Riquent in preventative and acute settings, officials said.

In the multi-dose study, about 45 patients, or 15 patients per group, will be treated weekly with 100 mg, 300 mg or 900 mg of Riquent for 12 weeks.

The trial design will allow the company to assess the effects of higher doses of Riquent while the study is being conducted, officials said.

Physicians and patients will be blinded to all data, but the company will be able to review data on an ongoing basis. The study will use the same doses that are being evaluated in the ongoing phase 3 clinical benefit trial of Riquent where the company is blinded to treatment, officials said.

"This trial will provide the first data on the ability of higher doses of Riquent to reduce pathogenic antibodies to [double-stranded] DNA in lupus patients. It will also enable us to continue to evaluate the potential benefit of Riquent for acute treatment of lupus renal flare as well as for preventative care," Steve Engle, chairman and chief executive officer, said in the release.

Published results from LaJolla's previous clinical trials indicate that a greater reduction in antibodies to double-stranded DNA results in a significantly lower risk of renal flare, Engle said.

The ongoing phase 3 study is being conducted under a Special Protocol Assessment with the Food and Drug Administration and is designed to demonstrate the clinical benefit of Riquent to delay time to renal flare.

A renal flare is a significant increase in inflammation in the kidney that destroys kidney tissue, reduces or stops kidney filtration and may result in the progression to end stage renal disease, the need for dialysis or death, officials said.

La Jolla is a San Diego biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe.

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